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Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00002478
Collaborator
National Cancer Institute (NCI) (NIH)
47
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16.

OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15 patients will be entered. The estimated duration of the study is 8 months.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer
Study Start Date :
Jun 1, 1993
Actual Primary Completion Date :
Oct 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic ovarian epithelial or cervical cancer Tissue not accessible for biopsy Refractory to curative therapy or established treatments and ineligible for higher priority GOG protocols Measurable disease required, as follows: Lesion measurable by physical exam Lesion bidimensionally measurable on sonogram or imaging Ascites/pleural effusion not measurable

    PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelets at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: Body surface area at least 1 square meter No requirement for intravenous hydration or nutritional support No significant infection No second malignancy other than nonmelanomatous skin cancer

    PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since anticancer therapy Chemotherapy: No more than 1 prior chemotherapy trial No prior etoposide At least 3 weeks since chemotherapy and recovered Endocrine therapy: At least 3 weeks since anticancer therapy Radiotherapy: At least 3 weeks since radiotherapy Surgery: At least 3 weeks since surgery and recovered

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033-0800
    3 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    4 Chao Family Comprehensive Cancer Center Orange California United States 92868
    5 Stanford University Medical Center Stanford California United States 94305-5408
    6 University of Colorado Cancer Center Denver Colorado United States 80262
    7 Vincent T. Lombardi Cancer Research Center, Georgetown University Washington District of Columbia United States 20007
    8 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    9 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    10 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    11 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    12 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    13 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    14 Indiana University Cancer Center Indianapolis Indiana United States 46202-5265
    15 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    16 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    17 Johns Hopkins Oncology Center Baltimore Maryland United States 21287
    18 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    19 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    20 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    21 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    22 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    23 Washington University School of Medicine Saint Louis Missouri United States 63110
    24 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    25 Cancer Center of Albany Medical Center Albany New York United States 12208
    26 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    27 University of Rochester Cancer Center Rochester New York United States 14642
    28 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-7775
    29 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    30 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    31 Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157-1082
    32 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    33 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    34 Cleveland Clinic Cancer Center Cleveland Ohio United States 44195
    35 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210
    36 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    37 Abington Memorial Hospital Abington Pennsylvania United States 19001
    38 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    39 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104
    40 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107
    41 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    42 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    43 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    44 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    45 Cancer Center, University of Virginia HSC Charlottesville Virginia United States 22908
    46 University of Washington Medical Center Seattle Washington United States 98195-6043
    47 Tacoma General Hospital Tacoma Washington United States 98405

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Peter G. Rose, MD, University Hospitals Seidman Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002478
    Other Study ID Numbers:
    • CDR0000077078
    • GOG-26LL
    First Posted:
    Jun 9, 2004
    Last Update Posted:
    Jun 10, 2013
    Last Verified:
    Nov 1, 2000
    Keywords provided by , ,
    recurrent cervical cancer
    recurrent ovarian epithelial cancer
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Etoposide

    Study Results

    No Results Posted as of Jun 10, 2013